17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''
FDA device recall Z-0107-04 · posted 2003-11-13 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics
- Reason for recall
- Plastic insert over articular surface of knee joint replacement may become dislodged.
- Action taken
- Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 35
- Distribution
- AZ, ID, TX CTdistributors.
- Date initiated
- 2003-08-01
- Date posted
- 2003-11-13
- Date terminated
- 2004-12-12
- Location
- San Diego, CA
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